2023 – Page 120 – 1stOncology™: Cancer Intelligence Service

Fosun Pharma USA Announces Abstract to be Presented at IASLC 2023 North America Conference on Lung Cancer (NACLC)

On November 28, 2023 Fosun Pharma USA Inc. ("Fosun Pharma USA") reported its abstract on ASTRIDE (NCT05468489), a phase 3 randomized, open-label study of serplulimab vs atezolizumab both in combination with chemotherapy (Carboplatin-Etoposide) in patients with extensive-stage small-cell lung cancer (ES-SCLC), has been accepted for presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2023 North America Conference on Lung Cancer (NACLC), being held in Chicago, Illinois, Dec. 1 – 3, 2023 (Press release, Fosun Pharma, NOV 28, 2023, View Source [SID1234638024]).

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All abstracts accepted for presentation have been published on the NACLC website.

"Our PIs are excited to present their poster on the design of the ASTRIDE Trial in Progress (TiP), which is an important milestone for the lead investigators and authors," said Stan Lechpammer, Vice President, Medical Affairs, Innovative Medicines, Fosun Pharma USA. "This presentation provides greater insight into the ASTRIDE trial that investigates serplulimab as a potentially new therapeutic option for extensive-stage (ES) small-cell lung cancer patients (SCLC). SCLC is an aggressive malignancy, with the majority of patients presenting with extensive-stage disease at initial diagnosis. There is a high unmet need for this patient population. Beyond the potential of our TiP study design, we have committed to recruiting patients from many medically underserved communities, to address health disparities and improve health equity for ES-SCLC patients in the U.S."

Abstract accepted for presentation’s details and key points about the study design:

Medicine

Abstract Title

Presentation Details

Serplulimab

Serplulimab vs atezolizumab added to chemotherapy in patients with treatment-naive ES-SCLC in the United States – ASTRIDE Trial in Progress

Abstract #: PP01.35

Poster available:

December 2 at 5:40 PM CST/6:40 PM EST

Key Highlights about Study Design

Trial will include approximately 200 adult patients with treatment-naïve ES-SCLC
Study participants are being recruited from over 90 sites across the United States
About Serplulimab
Serplulimab is a novel anti–PD-1 (programmed cell death-1) monoclonal antibody (mAb), with a unique mode of recognition of the PD-1 receptor compared with currently available anti–PD-1 mAbs (Issafras et al. Plos One. 2021).

About the ASTRIDE Phase 3 Trial
ASTRIDE is a randomized, open-label study of serplulimab plus chemotherapy (carboplatin-etoposide) compared with atezolizumab plus chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) in the United States. The primary objective for ASTRIDE is to confirm the applicability of the results of ASTRUM-005 (a global, randomized, phase 3 trial) to patients in the United States, with the current standard-of-care as the control arm, based on comments from the U.S. Food and Drug Administration (Serplulimab study protocol 2.0 final. Shanghai Henlius Biotech, Inc.; July 18, 2022).

About Small-cell Lung Cancer
Approximately 30,000-35,000 people are diagnosed with small-cell lung cancer (SCLC) each year in the United States. It is the most aggressive form of lung cancer with approximately 70% of patients presenting with extensive-stage disease (ES-SCLC), with a median overall survival of approximately 12.5 months with standard-of-care treatment.

Orlance Inc. Awarded NIH SBIR Grant for Next Generation Gene-Gun Delivered DNA and RNA Immunotherapeutic Vaccines for Melanoma

On November 28, 2023 Orlance, Inc., a Seattle biotech developing next-generation DNA and RNA vaccines and therapeutics, reported that the company has been awarded a National Institutes of Health (NIH) Phase I Small Business Innovation Research (SBIR) grant to use its needle-free MACH-1 platform for creating a vaccine regimen that induces strong tumor specific immune responses and protection from melanoma (Press release, Orlance, NOV 28, 2023, View Source [SID1234638023]).

The MACH-1 platform is a high-performance microparticle ‘gene gun’ technology that efficiently and uniquely delivers DNA or RNA vaccine-coated microparticles directly into cells in the epidermis, the uppermost layer of the skin. The epidermis is rich in immune-stimulating cells. MACH-1 delivery harnesses this environment and the natural machinery of its immune cells to deliver DNA and RNA vaccines or therapeutics; these encode proteins that trigger potent immunity including generation of antibodies to block an infection and activation of T cells that can either eliminate infected cells or kill tumor cells. Unlike current licensed mRNA vaccines, MACH-1-delivered vaccines are stable at room temperature, are painless and needle-free, and can trigger protective levels of immunity or efficacy with much lower doses.

While personalized cancer antigens have been identified from patients’ tumors, effective methods to deliver these antigens and stimulate specific immune responses are still lacking. MACH-1 stable, painless, targeted, and lose-dose DNA and RNA vaccines show promise for addressing these shortcomings in melanoma treatment, based upon MACH-1 data in other relevant models. Researchers aim to enhance MACH-1’s effectiveness by exploring combinations of genetic enhancers (adjuvants) and DNA or RNA formulations in comparison to other delivery methods in mice.

"Orlance is thrilled that our MACH-1 technology has broad applicability in both infectious disease and oncology. Our preclinical accomplishments in vaccines for viral infections have caught the eye and generated rapid enthusiasm among multiple cancer collaborators, including the National Cancer Institute (NCI) via this SBIR award," stated Kristyn Aalto, Orlance CEO. "Overall, we’re seeing the field recognize the attributes of targeting the skin itself, rather than deeper tissues, as the ideal immunologic tissue and dosing site for DNA and RNA vaccines. We are confident that MACH-1’s standalone ability to delivery specifically into the epidermis will continue to yield strong results across multiple disease targets. Melanoma is an exciting first crossover into cancer for us due both to unmet need and its perfect skin-targeting opportunity." This new SBIR grant, led by Orlance’s Dr. Hannah Frizzell, PhD, will enable Orlance to complete proof of concept, formulation, and adjuvant incorporation necessary to advance lead candidates into later-stage preclinical development activities and IND readiness. If successful, program output will be a vaccine candidate shown to induce significantly slower tumor outgrowth in preclinical models that also incorporates all MACH-1 stability, dose-sparing, tissue targeting, and needle-free advantages.

This award brings Orlance’s SBIR funding total to $12.9M to advance next-generation DNA and RNA vaccines and therapeutics. Orlance was founded as a University of Washington spin out company in 2016 to develop the MACH-1 platform based on technology invented by Deborah Fuller, PhD, Professor of Microbiology at the University of Washington School of Medicine. Orlance plans to initiate Phase 1 clinical trials for the company’s lead infectious disease asset in 2025.

PRISM BioLab and Lilly Enter into a Drug Discovery Collaboration on a Protein-Protein Interaction Target

On November 28, 2023 PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI) targets, reported that it has entered into a License and Collaboration Agreement with Eli Lilly and Company ("Lilly") (Press release, PRISM Pharma, NOV 28, 2023, View Source [SID1234638022]).

Under the agreement, PRISM and Lilly will collaborate to discover small molecule inhibitors of a PPI target selected by Lilly utilizing PRISM’s proprietary PepMetics technology. Lilly has the option to add up to two more targets to the collaboration and is responsible for the clinical development and commercialization of resulting products. PRISM will receive upfront payments and is eligible to receive up to $660 million in pre-clinical, clinical and commercial development milestones payments, as well as royalties on product sales.

"We are very excited to enter into this collaboration with Lilly as we apply our technology to expand the field of drug discovery into a novel approach to drug the PPI targets," said Dai Takehara, President and Chief Executive Officer of PRISM Biolab. "Our PepMetics technology holds promise to change the current paradigm in drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules. This collaboration with Lilly, an innovative global pharma company, could help us realize this vision and expand the field of druggable targets for the benefit of patients."

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health to Showcase Expansive Portfolio of Hematology/Oncology Data at the 65th American Society of Hematology Annual Meeting and Exposition

On November 28, 2023 Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health reported that it will present an extensive array of hematology/oncology data from their clinical research program at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held in San Diego, California (and virtually) from December 9-12, 2023 (Press release, Rutgers Cancer Institute of New Jersey, NOV 28, 2023, View Source [SID1234638021]). A total of 36 abstracts have been accepted, comprising clinical data and analyses that advance the understanding, treatment, and prognosis of blood cancers such as lymphoma, leukemia, and myeloma. Rutgers Cancer Institute of New Jersey, in partnership with RWJBarnabas Health, is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.

"Our devoted and highly esteemed team of cancer specialists and researchers at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health remain dedicated to pioneering advancements that transform treatments, patient care, and outcomes by leveraging innovation and evolving novel therapies," said Matthew Matasar, MD, MS, Chief of Blood Disorders at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health. "As the leading cancer program in the state, our commitment to advancing oncology care is unwavering. We strive to make a meaningful difference in the lives of those affected by cancer, and through innovative science and research, we can uncover new insights that may transform the landscape of cancer care in the future."

Highlights of the accepted abstracts include the following oral and poster presentations:

Data from a randomized phase 3 trial conducted by the National Clinical Trials Network evaluating the tolerability and progression-free survival rate of Nivolumab-AVD compared to Bv-AVD in patients aged ≥60 with newly diagnosed advanced-stage Hodgkin lymphoma (AS-HL). The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), event-free survival (EFS), and detailed toxicity and safety events. Response and progression were assessed by investigators using 2014 Lugano Classification.
Data from a phase 3 trial evaluating the progression-free survival and toxicity with Nivolumab-AVD compared to Bv-AVD in pediatric patients aged ≥12 years with stage 3-4 Classic Hodgkin Lymphoma (cHL). The trial was led by SWOG and conducted by the National Clinical Trials Network. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival (OS), event-free survival (EFS), and safety.
Evaluation of the A-HIPI model in generating risk groups with input on strengths and limitations for patients with advanced stage classical Hodgkin lymphoma (AS-HL). This prognostic model, developed and validated by the Hodgkin Lymphoma International Study for Individual Care (HoLISTIC) Consortium, generates the individualized probability of a progression-free survival (PFS) event or death within the first 5 years from diagnosis in patients based on continuous variables.
Development and validation of the modern-day model, E-HIPI, in the prediction of progression-free survival of early-stage Hodgkin lymphoma (E-HL) within the first five years since diagnosis. The model incorporates detailed individual patient data from international clinical trials and prospective registry data that were standardized, normalized, and harmonized as part of the HoLISTIC Consortium. The primary outcome was progression-free survival (PFS).
Data from a clinical trial evaluating the feasibility, safety, and efficacy of home-based intravenous administration of trans-retinoic acid (ATRA) and arsenic trioxide in the treatment of Acute Promyelocytic Leukemia (APL). Patients were given the option of receiving at-home treatment through a partnership with Qualitas Specialty Pharmacy and were evaluated for any adverse effects.
The full list of presentations at this year’s ASH (Free ASH Whitepaper) Annual Meeting and Exposition follows:

Oral Presentations

Abstract and
Session No.

Title

Presentation Date/Time

Abstract 181
(Session 624)

Nivolumab-AVD Is Better Tolerated and
Improves Progression-Free Survival
Compared to Bv-AVD in Older Patients
(Aged ≥60 Years) with Advanced Stage
Hodgkin Lymphoma Enrolled on SWOG
S1826 Clinically Relevant Abstract

Saturday, December 9, 2023:
2:00 PM PT

Abstract 308
(Session 627)

Improved Survival of R/R Double Hit/Triple
Hit Lymphoma in the Era of CD19 Chimeric
Antigen T Cell (CART) Therapy

Saturday, December 9, 2023:
4:15 PM PT

Abstract 382
(Session 905)

Treatment Patterns and Outcomes for Patients
with Classic Hodgkin Lymphoma (cHL) and
Cardiomyopathy with Low Ejection Fraction
(EF): Real-World Evidence (RWE) from 16
US Academic Centers

Saturday, December 9, 2023:
4:45 PM PT

Abstract 497
(Session 905)

Outcomes of Patients with Richter
Transformation without Prior
Chemoimmunotherapy for CLL/SLL: An
International Multicenter Retrospective Study

Sunday, December 10, 2023:
10:30 AM PT

Abstract 603
(Session 623)

Mosunetuzumab Monotherapy Continues to
Demonstrate Durable Responses in Patients
with Relapsed and/or Refractory Follicular
Lymphoma after ≥2 Prior Therapies: 3-Year
Follow-up from a Pivotal Phase II Study

Sunday, December 10, 2023:
5:00 PM PT

Abstract 607
(Session 624)

Results from an Intergroup Randomized
Phase II Study of the Combinations of
Ipilimumab, Nivolumab and Brentuximab
Vedotin in Patients with Relapsed/Refractory
Classic Hodgkin Lymphoma: A Trial of the
ECOG-ACRIN Research Group (E4412)

Sunday, December 10, 2023:
4:30 PM PT

Abstract 610
(Session 624)

Progression-Free Survival (PFS) and Toxicity
with Nivolumab-AVD Compared to
Brentuximab Vedotin-AVD in Pediatric
Advanced Stage (AS) Classic Hodgkin
Lymphoma (cHL), Results of SWOG S1826

Sunday, December 10, 2023:
5:15 PM PT

Abstract 614
(Session 627)

Mosunetuzumab Monotherapy Demonstrates
Activity and a Manageable Safety Profile in
Patients with Relapsed or Refractory
Richter’s Transformation

Sunday, December 10, 2023:
4:45 PM PT

Abstract 981
(Session 623)

Pirtobrutinib in Relapsed/Refractory (R/R)
Mantle Cell Lymphoma (MCL) Patients with
Prior cBTKi: Safety and Efficacy Including
High-Risk Subgroup Analyses from the Phase
1/2 BRUIN Study

Monday, December 11, 2023:
5:00 PM PT

Poster Presentations

Abstract and
Session No.

Title

Presentation Date/Time

Abstract 1079

(Session 101)

Congenital Dyserythropoietic Anemia Type
II: An Update from the Congenital
Dyseryhtropoietic Anemia Registry of North
America (CDAR)